MEMANTINE 20 mg. 28 tablets
How Does Memantine Accord Work:
Memantine Accord belongs to a group of medicines known as anti-dementia drugs. The loss of memory in Alzheimer's disease is due to disturbances in signal signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors involved in transmitting nerve signals that are important to learning and memory.
Memantine Accord belongs to a group of medicines called NMDA receptor antagonists. Memantine Accord acts on these NMDA receptors, improving the transmission of nerve signals and memory.
What is Memantine Accord used for?
Memantine Accord is used to treat patients with moderate to severe Alzheimer's disease.
2. What you need to know before you take Memantine Accord
Do not take Memantine Accord:
If you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine Accord:
If you have a history of epileptic seizures;
If you have recently had myocardial infarction (heart attack) or if you have congestive heart failure or uncontrolled hypertension (high blood pressure).
In these situations, treatment should be closely monitored and the clinical benefit of Memantine Accord evaluated by your doctor.
If you have impaired kidney function (kidney damage), your doctor should carefully monitor renal function and, if necessary, adjust memantine doses accordingly.
Taking medicinal products at the same time as amantadine (for the treatment of Parkinson's disease), ketamine (a substance commonly used for anesthesia), dextromethorphan (usually used to treat cough) and other NMDA-antagonists should be avoided.
Children and adolescents
Memantine Accord is not recommended in children and adolescents under the age of 18 years.
Other Drugs and Memantine Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine Accord may change the effects of the following medicines, and your doctor may need to adjust their dose:
amantadine, ketamine, dextrametrorphan;
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
hydrochlorothiazide (or a combination with hydrochlorothiazide);
anticholinergic agents (substances commonly used to treat motor disorders or intestinal spasms);
anticonvulsants (substances used to prevent or treat seizures);
barbiturates (substances normally used to induce sleep);
dopaminergic agonists (substances such as L-dopa, bromocriptine);
neuroleptics (substances used to treat psychiatric disorders);
If you go to a hospital, tell your doctor that you are taking Memantine Accord.
Memantine Accord with food and beverages
Tell your doctor if you have recently changed or plan to change your diet drastically (for example from a normal diet to a strict vegetarian diet) or if you have kidney tubular acidosis (BTA), an excess of acidic substances in your blood due to impaired kidney function poor functioning of the kidneys)) or severe infections of the urinary tract (urinary tract), as dose adjustment of the drug may be necessary.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or are planning to become pregnant. The use of memantine by pregnant women is not recommended.
Women who are taking Memantine Accord should not breast-feed.
Driving and using machines
Your doctor will tell you if the disease allows you to drive and operate machines safely.
In addition, Memantine Accord may change your ability to respond, which may cause you to drive or operate machinery.
Memantine Accord contains lactose.
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product for advice.
3. How to take Memantine Accord
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Memantine Accord in adults and elderly patients is 20 mg once a day. To reduce the risk of side effects, this dose is progressively reduced to the following daily regimen. Dosing tablets containing different doses are available for gradual dose escalation.
At the beginning of treatment, you will start by taking Memantine Accord 5 mg film-coated tablets once a day. This dose will be increased each week by 5 mg until the recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a day and is reached at the beginning of the 4th week.
Dosage in patients with impaired renal function
If you have impaired kidney function, your doctor will decide what dose is appropriate for your condition. In this case, your doctor should monitor your kidney function at regular intervals.
Memantine Accord should be administered orally once a day. In order to benefit from the drug, you should take it regularly, every day at the same time of the day. The tablets should be swallowed with some water. Tablets can be taken with or without food.
Duration of treatment
Taking Memantine Accord continues until it has an effect on you. Your doctor should re-evaluate your treatment.
If you take more than the necessary dose of Memantine Accord
Normally, taking too much Memantine Accord should not harm you. There may be some symptoms listed in section 4. "Possible side effects".
If you take Memantine Accord at a dose much higher than prescribed, contact your doctor or seek medical advice as you may need medical attention.
If you forget to take Memantine Accord
If you find you have forgotten to take your dose of Memantine Accord, wait for the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, please consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually, the undesirable effects observed are mild to moderate.
Common (may affect up to 1 in 10 people):
Headache, drowsiness, constipation, increased functional liver function, dizziness, disturbance of balance, shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):
Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure and venous thrombosis (thrombosis / thromboembolism).
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency can not be estimated from the available data):
Inflammation of the pancreas, inflammation of the liver and psychotic reactions.
Alzheimer's disease is associated with depression, suicidal thoughts, and suicide attempts. These events have been reported in patients treated with memantine.
If any of the side effects gets serious, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Memantine Accord
Keep out of the reach and sight of children.
Do not use Memantine Accord after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
Packaging content and additional information
What contains Memantine Accord
The active ingredient is memantine hydrochloride. Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, silica, colloidal anhydrous, crospovidone, magnesium stearate, all of which are in the tablet core; polysorbate 80, macrogol 400, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) are contained in the tablet coat.
What the Memantine Accord looks like and what the package contains
Mementin Accord film-coated tablets are pale red to gray-red elongated, scored scored tablets with a debossed "MT" on one side, divided by the score line and "20" on the other side, separated by the score line. The tablet can be divided into two equal doses.
Film-coated tablets Memantine Accord are available in blister packs (PVC / PE / PVDC-Aluminum blister) of 14 tablets, 28 tablets, 42 tablets, 56 tablets and 98 tablets.
Not all pack sizes may be marketed.